BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 300

    MDR report key: 3663228 · Received December 20, 2013

    Report

    Report Number
    1217183-2013-00022
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 19, 2013
    Report Date
    December 20, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LAB REQUESTED THE BACK UP INFO FROM THE INSTRUMENT AT THIS TIME. CUSTOMER RESPONDED AND INDICATED THAT NO BACK UP WILL BE SENT. INSTRUMENTATION LAB IS UNABLE TO CONTINUE THEIR INVESTIGATION WITHOUT AN INSTRUMENT BACK UP.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEIR ACL TOP 300 ANALYZER WAS RUNNING HIGH QC FOR PT AND APTT RESULTS WERE LOW. APTT-SS RESULT OF 38 WAS GIVEN, TARGET WAS 57.8. THE CUSTOMER REQUESTED QC AND GOT A RESULT OF 57.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670793 ACL TOP 300 COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-60

    Patients

    Seq Age Sex Outcome Treatment
    1